Status:
RECRUITING
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
The Duke Endowment
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a multiple inter...
Detailed Description
Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to infection) are discharged from U.S. hospitals annually, facing high rates of long-term mortality and morbidity ...
Eligibility Criteria
Inclusion
- adults 18 years of age and older;
- clinically suspected infection
- two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND
- antibiotics initiated within 24 hours and continued for at least one additional day
- organ dysfunction
- two or more points on admission Sequential Organ Failure Assessment (SOFA); OR
- two or more points on admission quick-SOFA
- deemed to be at high risk of hospital readmission within 90 days, defined as readmission risk probability of at least 25%
- not discharged from the hospital at the time of patient identification each morning.
Exclusion
- change in code status (i.e., initially full code followed by change to do not resuscitate and/or do not intubate) within 24 hours after index presentation due to presumed limitation of aggressive treatment and exposure to STAR program components;
- reside \> 2.5 hours drive time from the treating hospital due to the maximum reach of the community services leveraged within the STAR program and the general assumption that these patients may have less comprehensive utilization tracking within available electronic record systems for study outcomes;
- are actively participating in a different care management program (e.g., cancer care patient navigation) documented in the electronic health record (EHR) at time of hospital admission.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT05997420
Start Date
January 16 2024
End Date
December 1 2025
Last Update
October 9 2025
Active Locations (1)
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1
Atrium Health
Charlotte, North Carolina, United States, 28203